Green TeaBotany-Camillia sinensis leaves

black tea-fully fermented leaves that are roasted;40mg caffeine/cup

green tea-steamed, dried, nonfermented leaves;20mg/cupoolong tea-partially fermentedwhite tea-steamed leaf buds;15mg/cup

Chemistry-the hot water extract of the leaves contains oligomericproanthocyanidins (OPCs) and other antioxidant/free radical scavengingcompounds; green and white tea have mainly catechins and flavanols,black tea has theaflavins

Pharmacology-protective activity against experimental cancers inanimals and some epidemiological evidence for protective effects forstomach, colon, esophogeal, pancreatic cancers and lower cardiovasculardisease risk but these are observational not prospective, controlled trials.There are some new, very promising preliminary studies recentlypublished, however.

EGCG=epigallocatechin-3-gallate

Uses and Evidence Topical use: a special extract with catechins is

available on Rx for genital warts (Veregen, DoakDermatologics)

Cancer prevention: some preliminary evidence forprostate cancer (Bettuzzi et al. Cancer Res2006;66:1234-1240. n=64 ) and cervical dyplasia(Ahn et al. Eur J Cancer Prev. 2003;12:383-90).

Also high consumption associated with lower riskfor bladder, esophogeal and pancreatic cancers.

Heart Disease: some preliminary evidence forimproved cholesterol levels (see slide)

Henning et al. Am J Clin Nutr 2004;80:1558-64. N=30GTS=Pharmanex; all had equal EGCG dose

Archiv Intern Med 2003;163:1448-1453 n=240 12 weeks usedtheaflavin enriched green tea extract in capsule form

<0.01P value

3.3Green tea extract

30placebo

Table 2. Prevalence of prostate cancer in placebo arm and GTC arm(12 months biopsy checkpoint)

Bettuzzi et al. Cancer Res 2006;66:1234-1240. n=64 with earlysigns of dysplasia; used capsules of a catechin enriched teaextract

Study arm prevalence of cancer (%)

June 30, 2005, FDA denied health claim for Green Tea1. "Two studies do not show that drinking green tea reduces the risk of

breast cancer in women, but one weaker, more limited study suggests that

drinking green tea may reduce this risk. Based on these studies, FDA

concludes that it is highly unlikely that green tea reduces the risk of

breast cancer."

2. "One weak and limited study does not show that drinking green tea

reduces the risk of prostate cancer, but another weak and limited study

suggests that drinking green tea may reduce this risk. Based on these

studies, FDA concludes that it is highly unlikely that green tea reduces

the risk of prostate cancer."

Green Tea Summary

Efficacy: Increased consumption may be somewhatprotective against certain cancers and heart disease.

Safety: good; caffeine content is significant; severalreports of hepatotoxicity associated with green teaextracts. Causal?

Drug interactions: antihypertensives? (caffeine);does contain vitamin K so large amounts mightcounteract warfarin.

Product selection: Most are not standardized toOPCs

Dose: tea? Maybe 3 cups/d; extracts? Maybe 200mgTID.

Questions remaining:• How much benefit and how much tea consumption? Black

tea? Do capsules act the same as the tea? What tostandardize on?

Evening Primrose Oil

Botany

Oenothera biennis., a wildflower/weed on the East USA coast

The seed is pressed to yield an oil

History

Many native American uses for the plant

Recent years have focused on the uses of the seed oil

Chemistry

•Seed contains about 14% oil of which half isgamma linolenic acid (GLA); this is a omega –6essential fatty acid;

•note: omega –3 fatty acids are present in fishoils and flaxseed oils and have different uses(e.g. lower cholesterol and risk of cancer

•GLA is a precursor to prostaglandin E1 whichmodulates (reduce) inflammation

•Other rich sources of GLA are borage seed oil(20%GLA) and black current oil (15% GLA)

6,9,12 octadecatrienoic acid

Linoleic is 9,12 octa decadienoic acid-plentiful in diet

Pharmacology of GLA

•GLA is precursor to several prostaglandins and leukotrienes thatinfluence pain and inflammation

•The idea is to “flood the system” with precursor to enhancesynthesis.

•Linoleic acid is an essential amino acid widespread in our diet

•GLA is formed from linoleic acid and is not found in common foods

Uses of GLA and Evening Primrose Oil

• Cyclic mastalgia

•PMS

•Diabetic neuropathy

•Eczema

•Arthritis, fatigue, digestive, asthma, weight loss, and many others

Evidence

•The evidence is surprisingly weak for most uses

•Several placebo controlled trials in the 1980s showing improvement in breast painassociated with menses; a recent study showed no effect (Am J Obstet Gynecol.2002 Nov;187(5):1389-94).

•No strong evidence to show improvement of other symptoms of PMS or postmenopausal symptoms

•Eczema use has been not effective in recent studies

•Use in diabetic neuropathy and rheumatoid arthritis looks promising based on asmall number of older controlled studies

•More evidence is needed to support use of EPO in Raynauds syndrome, ADD,osteoporosis,as an adjunct treatment for breast cancer,for obesity,andhyperlipidemias

Safety

No special concerns at present

Dose: 2-6g of EPO/d or even higher

Evening Primrose Oil Summary

Efficacy: uneven evidence for most uses; best fordiabetic neuropathy, cyclic breast pain, and possiblyrheumatoid arthritis. May have application inhelping treat breast cancer.

Safety: good Drug interactions: none noted so far but increased

blood clotting time has been noted. Caution withwarfarin.

Product selection: Efamol is the best studied; has1g/capsule

Dose: 2-6g/d Questions remaining include

• Does EPO really work for its many suggested uses?

Valerian

Botany Valeriana officinalis, garden heliotrope roots and rhizomes used

• powder• tincture

History roots long used as tranquilizer and sedative

Valerian Chemistry

0.1%-0.3% volatile oil in roots contains sesquiterpenes e.g. valerenic acid contains valepotriates contains baldrinal and other decomposition products

Pharmacology volatile oil is sedative in animals valepotriates have tranquilizer activity water extract is sedative and has neither! ? Active components in vitro-

• aqueous extracts causes release of GABA (similar tobenzodiazepines)

• inhibit GABA breakdown mechanism unknown, active components unknown!

Vorbach et al. Psychopharmakotherapie 3:109-115,1996

Donath et al. Pharmacopsychiatry 2000;33:47-53. N=16; valerian for14d; crossover study

Ziegler et al. European J Med Res 2002;7:480-486. N=202

Enrolled(n=23)

Randomized(n=16)

Allocated tovalerian first (n=8)

Allocated toplacebo first (n=8)

Excluded (n=7), alldue to sleep apneaon screening night(5 male, 2 female).

Analyzed outcomes:

PSG (n=8)Subjective (n=8)Actigraphy (n=7)

Analyzed outcomes:

PSG (n=8)Subjective (n=8)Actigraphy (n=7)

D. M Taibi, M. V. Vitiello, S. Barsness, G. D. Anderson, G. W. Elmer, and C. A. Landis “Arandomized clinical trial of valerian fails to improve subjective and objecctive sleep quality of

older women with sleep distrubance” Sleep Med in press, 2008.

Results: no difference between placebo and valerianin subjective and objective sleep in this UW study

Valerian Precautions

drowziness, avoid alcohol restlessness,nausea worry over valepotriate epoxide (liver damage) but

commercial products have little not pregnancy, not infants, not nursing limit use to 2 weeks, withdrawal signs have been

reported but these reports are suspect acute overdose (20x) gave only mild effects

Dose 400mg –600mg of an extract at hs 2-3g of powder to make tea 1-3ml of tincture

Products valerenic acid as marker

Valerian Summary

Efficacy: long historical use; limited number ofcontrolled studies. Some show efficacy. Acute usemay be ineffective. Recent studies are negativeincluding one we did.

Safety: good but be careful as with any sedative Drug interactions: none noted so far Product selection: many products failed

consumerlab.com’s testing Dose: about 600mg of a root extract at HS Questions remaining include

• How effective is this for occasional use?• How effective is this for chronic insomnia?

Horny Goat Weed (really!!)

•Botany Epimedium species, usually E. grandiflorum;leaves or root used

•History long used in traditional Chinese medicine (TCM) and called Ying Yang Huo

•Chemistry flavonoids, icariin (a flavonol glycoside), polysaccharides; active components are unknown

•Pharmacology animal studies show some effects in increasing semen, increasing growth ofprostate and testicular tissue, loweringblood pressure and decreasing plateletadhesion. In vitro inhibitory effects oncancer cells.

•Use impotence, aphrodisiac, tonic and a variety ofother uses in TCM including for heart disease

Horny Goat Weed

Evidence: animal studies support some hormonal effects and hypotensive action

Safety:a report of tachyarrythmia and hypomaniawith use in a patient with CHD.

Drug Interactions:caution with anti-plateletadhesion drugs, anticoagulants andantihypertensives

Products:no recommendations; most contain500mg crude plant; some are extracts

Summary:avoid this unproven and poorly studiedproduct